Rogers Sciences'mission is to provide effective, low morbidity and cost-effective cancer care through the development and commercialization of therapeutic systems based on Continuous Low Irradiance Photodynamic Therapy (CLIPT). The initial application and proof-of-principle of our technology is the treatment of chest wall progression of breast cancer. While conventional photodynamic therapy (PDT) has been in development and clinical use for over 30 years, it has not gained widespread adoption for a number of reasons including morbidities associated with the therapy, the complexity of administering the required photoactivation energy and the lack of tumor-specificity of the therapy. Our research aims to address these limitations with a new, low irradiance dosimetry approach and novel therapy delivery devices. Low irradiance therapy in animal models has demonstrated highly specific tumor kill with minimal morbidity and few of the side effects associated with conventional PDT. These promising pre-clinical results are changing thought-leader opinion regarding PDT and have spurred interest from the radiation oncology, medical and surgical oncology communities. Rogers Sciences has developed a first-generation prototype CLIPT System that is presently being used in a Phase I, dose-limiting toxicity (DLT) human clinical trial with highly promising results. The endpoints of the DLT trial are performance evaluation of the light delivery device used to deliver CLIPT therapy and determining the maximum tolerated dose (MTD) of light energy delivered over the 24 hour therapy. Building on the promising pre-clinical results and our preliminary human trial, the goals of this SBIR proposal are to refine the CLIPT light delivery device and evaluate system safety and clinical performance in preparation for future pre- clinical and clinical efficacy studies. Phase I of the proposed SBIR effort has two specific aims. The first aim is to characterize and improve the technical performance of the light delivery device through engineering redesign and bench testing. The second aim is to assess the performance of the redesigned light delivery device in a clinical setting to ensure the device is optimized for use in future clinical testing. Successful completion of both specific aims will establish the technical and clinical feasibility of the Rogers Sciences CLIPT light delivery device for use in the treatment of chest wall progression of breast cancer. Phase II of the research will involve further development of the CLIPT System and a larger scale clinical trial to evaluate the efficacy of CLIPT in a broader patient population. If CLIPT proves to be an effective treatment, this approach opens a new therapeutic paradigm that can be applied to a range of other cancers and proliferative diseases. PUBLIC HEALTH RELEVANCE: Post-mastectomy recurrence of breast cancer in the chest wall occurs in 5%-8% of cases, but it occurs more frequently in underserved populations and is highly stage-dependent, with incidence as high as 60% in some patient groups. Many patients have extensive disease that cannot be adequately controlled with conventional treatment and for patients that fail traditional radiation, surgery and chemotherapy, there are few therapeutic options available. This project seeks to develop a novel, low-morbidity approach to treating cancer that can be administered repeatedly and in an outpatient setting.